MAUDE Adverse Event Report: UNKNOWNGYRUS ACMI INC SHOCKPULSE PROBE; UNKNOWN

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The probe was returned stuck inside the transducer.Upon receipt the probe was observed to be damaged.The model and lot number of the probe were not recorded.Therefore, there is no record of an evaluation being performed.At the customer¿s request, the device was returned to the customer unrepaired.An investigation is ongoing to obtain additional information regarding this event.

Event Description

The service center was informed during preparation for use, there was a problem with the probe.There was no report of patient involvement.

Manufacturer Narrative

Upon further review by the legal manufacture at the time of device evaluation, it was observed that the device is not manufactured by olympus and does not need to be reported by olympus.The manufacturer of the device could not be determined from the device part that was returned.No information was received from the customer when due diligence was executed.Please see the updates in sections: g3, g6, h2, and h10.

• Brand Name: SHOCKPULSE PROBE
• Type of Device: UNKNOWN
• Manufacturer (Section D): UNKNOWNGYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 11247405
• MDR Text Key: 250462555
• Report Number: 3011050570-2021-00034
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00855279005023
• UDI-Public: 00855279005023
• Combination Product (y/n): N
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1